Trial Outcomes & Findings for Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030) (NCT NCT03940586)
NCT ID: NCT03940586
Last Updated: 2024-08-22
Results Overview
Blood was collected on treatment Day 7 from participants aged 2 to \<12 years in order to determine the AUC0-24 of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \> 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N \<2.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dose
Results posted on
2024-08-22
Participant Flow
Male and female recipients of a first allogeneic hematopoietic stem cell transplant (HSCT), between the ages of birth and \<18 years of age, who were at risk for cytomegalovirus (CMV) infection and/or disease, and who had undetectable CMV deoxyribonucleic acid (DNA) collected within 5 days before enrollment. were enrolled in this study.
Participant milestones
| Measure |
12 - <18 Years
Letermovir (LET) 480 mg without cyclosporin (CsA), or 240 mg with CsA, administered either orally as tablets or in granular form, or by intravenous (IV) infusion, once daily (QD) through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants ≥30 kg body weight (BW): LET 480 mg orally without CsA, or 240 mg with CsA, in granular form, or 240 mg IV with or without CsA; 18 to \<30 kg BW: LET 240 mg orally without CsA, or 120 mg with CsA, either in granular form, or 120 mg IV with or without CsA; 10 to \<18 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to \<10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to \<7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to \<5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
8
|
|
Overall Study
Treated
|
28
|
27
|
8
|
|
Overall Study
COMPLETED
|
21
|
21
|
6
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
2
|
Reasons for withdrawal
| Measure |
12 - <18 Years
Letermovir (LET) 480 mg without cyclosporin (CsA), or 240 mg with CsA, administered either orally as tablets or in granular form, or by intravenous (IV) infusion, once daily (QD) through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants ≥30 kg body weight (BW): LET 480 mg orally without CsA, or 240 mg with CsA, in granular form, or 240 mg IV with or without CsA; 18 to \<30 kg BW: LET 240 mg orally without CsA, or 120 mg with CsA, either in granular form, or 120 mg IV with or without CsA; 10 to \<18 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to \<10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to \<7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to \<5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Withdrawal By Parent/Guardian
|
3
|
4
|
1
|
|
Overall Study
Not Treated
|
0
|
2
|
0
|
Baseline Characteristics
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
Baseline characteristics by cohort
| Measure |
12 - <18 Years
n=28 Participants
LET 480 mg without CsA, or 240 mg with CsA, administered either orally as tablets or in granular form, or by IV infusion, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=27 Participants
Participants ≥30 kg BW: LET 480 mg orally without CsA, or 240 mg with CsA, in granular form, or 240 mg IV with or without CsA; 18 to \<30 kg BW: LET 240 mg orally without CsA, or 120 mg with CsA, either in granular form, or 120 mg IV with or without CsA; 10 to \<18 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=8 Participants
10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to \<10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to \<7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to \<5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
44 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
41 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Age, Continuous
|
14.1 Years
STANDARD_DEVIATION 1.5 • n=39 Participants
|
6.6 Years
STANDARD_DEVIATION 3.2 • n=41 Participants
|
0.7 Years
STANDARD_DEVIATION 0.3 • n=35 Participants
|
9.1 Years
STANDARD_DEVIATION 5.3 • n=31 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
44 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 - \<18 years in order to determine the AUC0-24 of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \< 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
n=5 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=4 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Plasma Letermovir Taken as Oral Formulation by Ages 2 - <18 Years
|
80300 hr*ng/mL
Geometric Coefficient of Variation 74.9
|
62900 hr*ng/mL
Geometric Coefficient of Variation 37.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 to \<12 years in order to determine the AUC0-24 of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \<2 and \>12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=2 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
AUC0-24 of Plasma Letermovir Taken as Oral Formulation by Ages 2 to <12 Years
|
—
|
39500 hr*ng/mL
Interval 23900.0 to 65200.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged \<2 years in order to determine the AUC0-24 of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged 2 - \<18 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N \<2.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=1 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
AUC0-24 of Plasma Letermovir Taken as Oral Formulation by Ages <2 Years
|
—
|
—
|
26200 hr*ng/mL
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 - \<18 years in order to determine the Cmax of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \< 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
n=5 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=4 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Maximal Concentration (Cmax) of Plasma Letermovir Taken as Oral Formulation by Ages 2 - <18 Years
|
7410 ng/mL
Geometric Coefficient of Variation 70.1
|
10800 ng/mL
Geometric Coefficient of Variation 17.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 to \<12 years in order to determine Cmax of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \<2 and \>12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=2 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Cmax of Plasma Letermovir Taken as Oral Formulation by Ages 2 to <12 Years
|
—
|
5500 ng/mL
Interval 5430.0 to 5580.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged \<2 years in order to determine the Cmax of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged 2 - \<18 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N \<2
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=1 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Cmax of Plasma Letermovir Taken as Oral Formulation by Ages < 2 Years
|
—
|
—
|
2950 ng/mL
|
—
|
PRIMARY outcome
Timeframe: Day 7: 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 - \<18 years in order to determine the Ctrough of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \< 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
n=5 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=4 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Minimum Concentration of Plasma Letermovir Observed Before Next Dose (Ctrough) Taken as Oral Formulation by Ages 2 - <18 Years
|
845 ng/mL
Geometric Coefficient of Variation 107.5
|
171 ng/mL
Geometric Coefficient of Variation 2046.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 to \<12 years in order to determine Ctrough of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \<2 and \>12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=2 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Ctrough of Plasma Letermovir Taken as Oral Formulation by Ages 2 to <12 Years
|
—
|
481 ng/mL
Interval 207.0 to 1120.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged \<2 years in order to determine the Ctrough of plasma letermovir for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged 2 - \<18 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N \<2.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=1 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Ctrough of Plasma Letermovir Taken as Oral Formulation by Ages < 2 Years
|
—
|
—
|
61.7 ng/mL
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 12 - \<18 years in order to determine the AUC0-24 of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \< 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
n=3 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
AUC0-24 of Plasma Letermovir Taken as Intravenous (IV) Formulation by Ages 12 - <18 Years
|
114000 hr*ng/mL
Geometric Coefficient of Variation 37.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 to \<12 years in order to determine the AUC0-24 of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \< 2 years and \> 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=2 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=2 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
AUC0-24 of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years
|
—
|
36200 hr*ng/mL
Interval 21000.0 to 62100.0
|
31500 hr*ng/mL
Interval 20300.0 to 48900.0
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 to \<12 years in order to determine the AUC0-24 of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \> 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N \<2.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=1 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
AUC0-24 of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years
|
—
|
25300 hr*ng/mL
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged \<2 years in order to determine the AUC0-24 of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \> 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N \<2.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=1 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
AUC0-24 of Plasma Letermovir Taken as IV Formulation by Ages <2 Years
|
—
|
—
|
37300 hr*ng/mL
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 12 - \<18 years in order to determine the Ceoi of plasma letermovir for participants receiving IV formulation. As samples were collected outside the collection window Ceoi for these samples were predicted by using a log linear model .Participants aged \< 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
n=3 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Concentration at the End of Infusion (Ceoi) of Plasma Letermovir Taken as IV Formulation by Ages 12 - <18 Years
|
30600 ng/mL
Geometric Coefficient of Variation 16.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 to \<12 years in order to determine the Ceoi of plasma letermovir for participants receiving IV formulation. As samples were collected outside the collection window Ceoi for these samples were predicted by using a log linear model. Participants aged \< 2 years and \> 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=2 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=2 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Ceoi of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years
|
—
|
16800 ng/mL
Interval 14900.0 to 19000.0
|
8200 ng/mL
Interval 7580.0 to 8870.0
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 to \<12 years in order to determine the Ceoi of plasma letermovir for participants receiving IV formulation. As samples were collected outside the collection window Ceoi for these samples were predicted by using a log linear model. Participants aged \> 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. A measure of dispersion is not determined when N \<2.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=1 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Ceoi of Plasma Letermovir Taken as IV Formulation by Ages s 2 to <12 Years
|
—
|
8630 ng/mL
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged \<2 years in order to determine the Ceoi of plasma letermovir for participants receiving IV formulation. As samples were collected outside the collection window Ceoi for these samples were predicted by using a log linear model. Participants aged \> 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. A measure of dispersion is not determined when N \<2.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=1 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Ceoi of Plasma Letermovir Taken as IV Formulation by Ages <2 Years
|
—
|
—
|
11700 ng/mL
|
—
|
PRIMARY outcome
Timeframe: Day 7: 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 12 - \<18 years in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \< 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
n=3 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Ctrough of Plasma Letermovir Taken as IV Formulation by Ages 12 - <18 Years
|
709 ng/mL
Geometric Coefficient of Variation 256.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged 2 to \<12 years in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \< 2 years and \> 12 years were not presented as their data analysis resulted in a different measure type and method of dispersion.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=2 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=2 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Ctrough of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years
|
—
|
71.6 ng/mL
Interval 12.9 to 397.0
|
318 ng/mL
Interval 134.0 to 754.0
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged \<2 years in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \> 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure of dispersion is not determined when N \<2.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=1 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Ctrough of Plasma Letermovir Taken as IV Formulation by Ages 2 to <12 Years
|
—
|
216 ng/mL
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7: Pre-dose, 1, 2.5, 8, and 24 hours post-dosePopulation: All participants with at least one measurable PK sample who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations.
Blood was collected on treatment Day 7 from participants aged \<2 years in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant. Participants aged \> 2 years were not presented as their data analysis resulted in a different measure type and method of dispersion. The measure type is Geometric Mean, and a measure of dispersion is not determined when N \<2.
Outcome measures
| Measure |
12 - <18 Years
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=1 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Ctrough of Plasma Letermovir Taken as IV Formulation by Ages <2 Years
|
—
|
—
|
98.3 ng/mL
|
—
|
PRIMARY outcome
Timeframe: Day 7: 24 hours post-dosePopulation: Per protocol, sparse PK results were not planned as either primary or secondary outcome measures. As sparse PK data were instead used in population PK model development, they were not summarized in this outcome measure.
Blood was collected on treatment Day 7 in order to determine the Ctrough of plasma letermovir during sparse PK for participants receiving oral formulation. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 7: 24 hours post-dosePopulation: Per protocol, sparse PK results were not planned as either primary or secondary outcome measures. As sparse PK data were instead used in population PK model development, they were not summarized in this outcome measure.
Blood was collected on treatment Day 7 in order to determine the Ctrough of plasma letermovir for participants receiving IV formulation during sparse PK. Individual values were natural log transformed and evaluated separately with a linear mixed effects model containing a fixed effect for treatment and a random effect for participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 48 post-transplant (up to 52 weeks)Population: All participants who received ≥1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The 95% confidence interval (CI) is based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
12 - <18 Years
n=28 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=27 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=8 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Percentage of Participants With One or More Adverse Event (AE)
|
100.0 Percentage of participants
Interval 87.7 to 100.0
|
100.0 Percentage of participants
Interval 87.7 to 100.0
|
100.0 Percentage of participants
Interval 63.1 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 14 post-transplant (up to 18 weeks)Population: All participants who received ≥1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The 95% CI is based on the exact binomial method proposed by Clopper and Pearson.
Outcome measures
| Measure |
12 - <18 Years
n=28 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=27 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=8 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Medication Due to an AE.
|
17.9 Percentage of participants
Interval 6.1 to 36.9
|
7.4 Percentage of participants
Interval 0.9 to 24.3
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
—
|
SECONDARY outcome
Timeframe: Up to Week 14 post-transplant (up to 18 weeks)Population: Participants who received ≥1 dose of study intervention, had no detectable CMV viral DNA on the day study intervention was initiated, had not prematurely discontinued from the study and had an outcome through week 14 post-transplant.
Clinically significant cytomegalovirus (CMV) infection is defined as CMV end organ disease (proven or probable) or initiation of pre-emptive therapy (PET) based on documented CMV viremia and the clinical condition of the participant. The 95% confidence interval (CI) was based on the exact binomial method proposed by Clopper and Pearson. Missing values: were handled by the Non-Completer=Failure (NC=F) approach. where failure was defined as all participants who developed clinically significant CMV infection or prematurely discontinued from the study or had a missing outcome through week 14 post-transplant visit window.
Outcome measures
| Measure |
12 - <18 Years
n=25 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=24 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=7 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant CMV Infection Through Week 14 Post-transplant
|
20.0 Percentage of participants
Interval 6.8 to 40.7
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
28.5 Percentage of participants
Interval 3.7 to 71.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24 post-transplant (up to 28 weeks)Population: Participants who received ≥1 dose of study intervention, had no detectable CMV viral DNA on the day study intervention was initiated, had not prematurely discontinued from the study and had an outcome through week 24 post-transplant.
Clinically significant CMV infection is defined as CMV end organ disease (proven or probable) or initiation of PET based on documented CMV viremia and the clinical condition of the participant. The 95% confidence interval (CI) was based on the exact binomial method proposed by Clopper and Pearson. Missing values: were handled by the Non-Completer=Failure (NC=F) approach. where failure was defined as all participants who developed clinically significant CMV infection or prematurely discontinued from the study or had a missing outcome through week 24 post-transplant visit window.
Outcome measures
| Measure |
12 - <18 Years
n=25 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=24 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=7 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant CMV Infection Through Week 24 Post-transplant
|
24.0 Percentage of participants
Interval 9.4 to 45.1
|
25.0 Percentage of participants
Interval 9.8 to 46.7
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 of administration of oral formulation up to Week 14 post-transplant (up to 18 weeks)Population: Participants who received ≥1 dose of study intervention, and completed palatability questionnaire
Palatability was measured by response to a questionnaire on the taste of medication , with responses from very good, good, neither good nor bad, bad or very bad.
Outcome measures
| Measure |
12 - <18 Years
n=4 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=27 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=7 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the First Day of Administration of Oral Formulation
Good
|
1 Participants
|
5 Participants
|
3 Participants
|
—
|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the First Day of Administration of Oral Formulation
Very good
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the First Day of Administration of Oral Formulation
Neither good nor bad
|
1 Participants
|
8 Participants
|
1 Participants
|
—
|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the First Day of Administration of Oral Formulation
Bad
|
1 Participants
|
8 Participants
|
3 Participants
|
—
|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the First Day of Administration of Oral Formulation
Very bad
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 8 of administration of oral formulation up to Week 14 post-transplant (up to 18 weeks)Population: Participants who received ≥1 dose of study intervention, and completed palatability questionnaire
Palatability was measured by response to a questionnaire on the taste of medication , with responses from very good, good, neither good nor bad, bad or very bad.
Outcome measures
| Measure |
12 - <18 Years
n=2 Participants
LET 480 mg without CsA as tablets or in granular form, was administered orally, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=23 Participants
Participants 18 to \<30 kg BW)received LET 240 mg without CsA orally in granular form QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
n=7 Participants
Participants 5 to \<7.5 kg BW received LET 60 mg orally without CsA, in granular form, QD through week 14 (\~ 100 days) post-transplant.
|
Birth - <2 Years
Participants 5.0 to \<7.5 kg BW received LET 40 mg without CsA, by IV QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|---|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the Eighth Day of Administration of Oral Formulation
Bad
|
0 Participants
|
5 Participants
|
0 Participants
|
—
|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the Eighth Day of Administration of Oral Formulation
Very good
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the Eighth Day of Administration of Oral Formulation
Good
|
1 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the Eighth Day of Administration of Oral Formulation
Neither good nor bad
|
1 Participants
|
8 Participants
|
4 Participants
|
—
|
|
Number of Participants Receiving Oral Granules With Palatability Response, Based on Taste of Medication on the Eighth Day of Administration of Oral Formulation
Very bad
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
Adverse Events
12 - <18 Years
Serious events: 13 serious events
Other events: 27 other events
Deaths: 4 deaths
2 - <12 Years
Serious events: 18 serious events
Other events: 27 other events
Deaths: 2 deaths
<2 Years
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
12 - <18 Years
n=28 participants at risk
LET 480 mg without CsA, or 240 mg with CsA, administered either orally as tablets or in granular form, or by IV infusion, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=27 participants at risk
Participants ≥30 kg BW: LET 480 mg orally without CsA, or 240 mg with CsA, in granular form, or 240 mg IV with or without CsA; 18 to \<30 kg BW: LET 240 mg orally without CsA, or 120 mg with CsA, either in granular form, or 120 mg IV with or without CsA; 10 to \<18 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
<2 Years
n=8 participants at risk
10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to \<10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to \<7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to \<5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
General disorders
Multiple organ dysfunction syndrome
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
General disorders
Pyrexia
|
10.7%
3/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Immune system disorders
Graft versus host disease
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Immune system disorders
Transplant rejection
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
BK virus infection
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Bronchitis bacterial
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Candida infection
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Cystitis viral
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Device related infection
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
25.0%
2/8 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Febrile infection
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Hepatosplenic candidiasis
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Klebsiella bacteraemia
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Septic shock
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Engraft failure
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Blood bilirubin increased
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Epstein-Barr virus test positive
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
1/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Vascular disorders
Venoocclusive disease
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
Other adverse events
| Measure |
12 - <18 Years
n=28 participants at risk
LET 480 mg without CsA, or 240 mg with CsA, administered either orally as tablets or in granular form, or by IV infusion, QD through week 14 (\~ 100 days) post-transplant.
|
2 - <12 Years
n=27 participants at risk
Participants ≥30 kg BW: LET 480 mg orally without CsA, or 240 mg with CsA, in granular form, or 240 mg IV with or without CsA; 18 to \<30 kg BW: LET 240 mg orally without CsA, or 120 mg with CsA, either in granular form, or 120 mg IV with or without CsA; 10 to \<18 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
<2 Years
n=8 participants at risk
10 to ≤15 kg BW: LET 120 mg orally without CsA, or 60 mg with CsA, in granular form, or 60 mg IV with or without CsA; 7.5 to \<10 kg BW: LET 80 mg orally without CsA, or 40 mg with CsA, either in granular form, or 40 mg IV with or without CsA; 5.0 to \<7.5 kg BW: LET 40 mg orally without CsA, or 20 mg with CsA, in granular form, or 20 mg IV with or without CsA; 2.5 to \<5.0 kg BW: LET 20 mg orally without CsA, or 10 mg with CsA, in granular form, or 10 mg IV with or without CsA, all QD through week 14 (\~ 100 days) post-transplant.
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
17.9%
5/28 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
2/28 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
29.6%
8/27 • Number of events 18 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
2/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.1%
2/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.6%
1/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
2/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
33.3%
9/27 • Number of events 12 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.9%
5/28 • Number of events 8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
40.7%
11/27 • Number of events 11 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Cardiac disorders
Tachycardia
|
14.3%
4/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Endocrine disorders
Hypothyroidism
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
39.3%
11/28 • Number of events 14 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
25.9%
7/27 • Number of events 11 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 7 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Anal fissure
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
4/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
14/28 • Number of events 20 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
48.1%
13/27 • Number of events 20 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Haematochezia
|
3.6%
1/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
12/28 • Number of events 25 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
29.6%
8/27 • Number of events 9 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
32.1%
9/28 • Number of events 9 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
33.3%
9/27 • Number of events 9 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
60.7%
17/28 • Number of events 47 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
77.8%
21/27 • Number of events 55 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
50.0%
4/8 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
General disorders
Asthenia
|
3.6%
1/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
14.8%
4/27 • Number of events 7 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
General disorders
Catheter site erythema
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
General disorders
Face oedema
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
General disorders
Fatigue
|
14.3%
4/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
14.8%
4/27 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
General disorders
Pyrexia
|
39.3%
11/28 • Number of events 18 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
48.1%
13/27 • Number of events 25 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
50.0%
4/8 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.1%
2/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Immune system disorders
Drug hypersensitivity
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Immune system disorders
Engraftment syndrome
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Immune system disorders
Graft versus host disease
|
35.7%
10/28 • Number of events 14 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
37.0%
10/27 • Number of events 13 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
37.5%
3/8 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Adenovirus infection
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
BK virus infection
|
10.7%
3/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Bacteraemia
|
10.7%
3/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Cytomegalovirus infection
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Device related infection
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Polyomavirus viraemia
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Rhinitis
|
7.1%
2/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Sepsis
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
4/28 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
BK polyomavirus test positive
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Blood creatinine increased
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Cytomegalovirus test positive
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Immunosuppressant drug level increased
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 7 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Oxygen saturation decreased
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Weight decreased
|
7.1%
2/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.7%
3/28 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
29.6%
8/27 • Number of events 10 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
7.1%
2/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.7%
3/28 • Number of events 7 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
18.5%
5/27 • Number of events 8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.9%
5/28 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
14.8%
4/27 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
17.9%
5/28 • Number of events 7 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
14.8%
4/27 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
2/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Malnutrition
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Neonatal diabetes mellitus
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Sodium retention
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
2/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
4/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
25.0%
7/28 • Number of events 11 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
14.8%
4/27 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Nervous system disorders
Tremor
|
14.3%
4/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.7%
3/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Renal and urinary disorders
Dysuria
|
21.4%
6/28 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Renal and urinary disorders
Haematuria
|
14.3%
4/28 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Renal and urinary disorders
Hypercalciuria
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Renal and urinary disorders
Renal impairment
|
10.7%
3/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
5/28 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
22.2%
6/27 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.7%
3/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.7%
3/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.7%
3/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.9%
5/28 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
14.8%
4/27 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.7%
3/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
14.8%
4/27 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
11.1%
3/27 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Nail pigmentation
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
8/28 • Number of events 9 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
14.8%
4/27 • Number of events 4 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.9%
5/28 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
14.8%
4/27 • Number of events 6 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Vascular disorders
Flushing
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Vascular disorders
Hypertension
|
28.6%
8/28 • Number of events 10 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
37.0%
10/27 • Number of events 14 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Vascular disorders
Hypotension
|
10.7%
3/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Eye disorders
Eye irritation
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Clostridium difficile colitis
|
3.6%
1/28 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 5 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Neutrophil count decreased
|
7.1%
2/28 • Number of events 3 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Investigations
Platelet count decreased
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
7.4%
2/27 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/28 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/27 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
2/28 • Number of events 2 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
3.7%
1/27 • Number of events 1 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
0.00%
0/8 • All-cause mortality (ACM): from allocation/randomization (i.e. prior to treatment) up to Week 48 post-transplant (up to 52 weeks). AEs: From first treatment up to Week 48 post-transplant (up to 52 weeks)
ACMs: the population analyzed was all allocated/randomized participants. AEs: the population analyzed was all allocated/randomized participants who received ≥1 dose of study intervention.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER